Recruiting.com
Recruiting. com is a recruitment platform that collects personal and non-personal information from job seekers to be used by recruiters and hiring managers. Users can submit their resumes or fill out a short form to be considered for current and future job opportunities. The site emphasizes user privacy and allows users to manage their personal data, including modifying, changing, and deleting their information. Recruiting. com securely stores user data until they request deletion, providing a comprehensive recruitment solution for both job seekers and employers.
career sites • recruiting software • employment brand • candidate relationship management • talent community
Senior Manager, Regulatory Affairs
3 days ago
Recruiting.com
Recruiting. com is a recruitment platform that collects personal and non-personal information from job seekers to be used by recruiters and hiring managers. Users can submit their resumes or fill out a short form to be considered for current and future job opportunities. The site emphasizes user privacy and allows users to manage their personal data, including modifying, changing, and deleting their information. Recruiting. com securely stores user data until they request deletion, providing a comprehensive recruitment solution for both job seekers and employers.
career sites • recruiting software • employment brand • candidate relationship management • talent community
📋 Description
• Support change applications including submission strategy. • Dossier compilation including preparation of documents and Table of Contents. • Content review of CMC/Labelling documentation. • Alignment with functions on variation procedures, deficiency letter, e.g, CMC, Medical Science. • Management of local RA requirements (local regulatory intelligence). • Cross-functional communication to all relevant departments in relation to regulatory strategy and submission. • Review of Promotional Materials.
🎯 Requirements
• Education Requirement: Life Science Degree (Pharmacy degree preferable) • Experience: At least 5-10 years of relevant experience in Regulatory Affairs • Skills and knowledge: Experience in the life cycle management of medicinal products and knowledge of the Health Authority requirements for the maintenance of medicinal product licences. • Regulatory strategy for successful submission to the Health Authority. • Experience in artwork management and supply strategy. • Communication with other local functions (Medical Affairs, Pharmacovigilance, Supply).
🏖️ Benefits
• Benefit offerings outside the US may vary by country and will be aligned to local market practice. • The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
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